The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
- Conditions
- Pleural Effusion
- Interventions
- Procedure: Ultrasound elastography guided pleural biopsyProcedure: Traditional ultrasound guided pleural biopsy
- Registration Number
- NCT05781659
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.
Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 592
- Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
- Sign the informed consent form
- The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation
- The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.
- The pleural fluid cytology proved to be malignant.
- Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.
- Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
- Coagulation dysfunction.
- transudate
- The age is less than 18 years old.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound elastography guided pleural biopsy group Ultrasound elastography guided pleural biopsy - Traditional ultrasound-guided pleural biopsy group Traditional ultrasound guided pleural biopsy -
- Primary Outcome Measures
Name Time Method Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion. 7 days after the biopsy The diagnosis would be confirmed according to the pathological results.
- Secondary Outcome Measures
Name Time Method Incidence rate of adverse events 7 days after the biopsy Symptoms and signs
Trial Locations
- Locations (9)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
Gui Zhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
the Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
the First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
the First People's Hospital of Yunnan Provience
🇨🇳Kunming, Yunnan, China
the Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
the First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The Tenth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China